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Kwang Je Lee,1 Jae-Kean Ryu,2 Yun-Hyeong Cho,3 Won Yong Shin,4 Jeong Su Kim,5 Young Won Yoon,6 Ji Yong Jang,7 Won Ho Kim,8 Jong Wook Beom,9 Seok-Min Kang10 On behalf of LG-VROS001 STUDY INVESTIGATOR GROUP1Department of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea; 2Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea; 3Cardiovascular Center, Myongji Hospital, Goyang, Korea; 4Department of Cardiology, Soon Chun Hyang University Hospital Cheonan, Cheonan, Korea; 5Cardiovascular Center, Pusan National University Yangsan Hospital, Yangsan, Korea; 6Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea; 7Department of Cardiology, National Health Insurance Service Ilsan Hospital, Ilsan, Korea; 8Eulji University School of Medicine, Daejeon, Korea; 9Department of Cardiology, Jeju National University Hospital, Jeju, Korea; 10Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, KoreaCorrespondence: Seok-Min Kang, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea, Tel +82 2-2647-3225, Email SMKANG@yuhs.acPurpose: This study aimed to assess the effectiveness and safety of a fixed-dose combination of rosuvastatin and valsartan (Rovatitan®) in Korean patients with concomitant hypertension and hyperlipidemia.Patients and Methods: A total of 1008 eligible patients with concomitant hypertension and hyperlipidemia were enrolled and treated for 12 weeks. Both upward and downward drug dose titrations were allowed based on the investigator’s discretion. This study evaluated the effectiveness of the study drug, defined by the percentage of patients achieving the blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) treatment targets. Additionally, regression analyses were conducted to evaluate the factors associated with the effectiveness and safety of the study drug. Of the 1008 patients enrolled in the study, 911 were analyzed for clinical effectiveness.Results: At 12 weeks, 84.6% and 75.9% of patients treated with the study drug achieved their BP and LDL-C targets, respectively, and 64.8% of patients achieved both targets simultaneously. Furthermore, the percentage of patients who achieved their BP and LDL-C treatment targets demonstrated a trend across the respective risk groups; the higher the risk group, the lower the success of attaining the respective target. This trend was also observed regardless of the prior antihypertensive and/or lipid-lowering treatments. According to regression analysis, poor metabolic profiles, including a higher body mass index (BMI) and higher BP and LDL-C levels at baseline, were significantly associated with treatment failure for BP. Among the 1005 patients included in the safety analysis, 17 patients (1.7%) experienced serious adverse events; however, none were considered related to the study drug.Conclusion: The study drug used for the treatment of concomitant hypertension and hyperlipidemia in a real-world setting was effective and was well tolerated. Therefore, the study drug is suggested as a good alternative to increase patient convenience and compliance, particularly in those taking multiple medications.Keywords: hypertension, hyperlipidemia, rosuvastatin, valsartan, effectiveness, safety

Background Optimal antiplatelet monotherapy during the chronic maintenance period in patients who undergo coronary stenting is unknown. We aimed to compare head to head the efficacy and safety of aspirin and clopidogrel monotherapy in this population. Methods We did an investigator-initiated, prospective, randomised, open-label, multicentre trial at 37 study sites in South Korea. We enrolled patients aged at least 20 years who maintained dual antiplatelet therapy without clinical events for 6-18 months after percutaneous coronary intervention with drug-eluting stents (DES). We excluded patients with any ischaemic and major bleeding complications. Patients were randomly assigned (1:1) to receive a monotherapy agent of clopidogrel 75 mg once daily or aspirin 100 mg once daily for 24 months. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium (BARC) bleeding type 3 or greater, in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02044250. Findings Between March 26, 2014, and May 29, 2018, we enrolled 5530 patients. 5438 (98·3%) patients were randomly assigned to either the clopidogrel group (2710 [49·8%]) or to the aspirin group (2728 [50·2%]). Ascertainment of the primary endpoint was completed in 5338 (98·2%) patients. During 24-month follow-up, the primary outcome occurred in 152 (5·7%) patients in the clopidogrel group and 207 (7·7%) in the aspirin group (hazard ratio 0·73 [95% CI 0·59-0·90]; p=0·0035). Interpretation Clopidogrel monotherapy, compared with aspirin monotherapy during the chronic maintenance period after percutaneous coronary intervention with DES significantly reduced the risk of the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and BARC bleeding type 3 or greater. In patients requiring indefinite antiplatelet monotherapy after percutaneous coronary intervention, clopidogrel monotherapy was superior to aspirin monotherapy in preventing future adverse clinical events. Funding ChongKunDang, SamJin, HanMi, DaeWoong, and the South Korea Ministry of Health and Welfare.

Background/aims To date, prospective data are limited on efficacy and safety profiles of statin therapy in Korean hypercholesterolemic patients. Hence, the aim of this study was to evaluate the practice patterns of statin therapy and its efficacy and safety through the prospective Daegu and Gyeongbuk statin registry. Methods Statin naive patients who were prescribed statins according to the criteria of Korean Guidelines for Management of Dyslipidemia were enrolled. Clinical and laboratory evaluations were performed at baseline and at week 8, where the efficacy was assessed with the same guidelines. Results Of 908 patients, atorvastatin and rosuvastatin were most frequently prescribed statins (63.1% and 29.3%, respectively). High intensity statins (atorvastatin 40 mg or rosuvastatin 20 mg) were prescribed in 24.7% of all patients and in 79.5% of high and very high risk groups. The total and low density lipoprotein (LDL) cholesterol levels decreased from 203.7 ± 43.0 to 140.6 ± 28.6 mg/dL and 134.4 ± 35.7 to 79.5 ± 21.3 mg/dL, respectively. The achievement rate of the LDL target goal was 98.6% in low risk, 95.0% in moderate risk, 88.1% in high risk, and 42.1% in very high risk patients (59.7% in overall). There was no significant difference in the efficacy between atorvastatin and rosuvastatin. Adverse events were observed in 12.0% of patients and led to 1.4% of treatment cessation. Conclusion The efficacy of the usual starting dose of statins in daily practice was relatively insufficient for Korean hypercholesterolemic patients with high or very high risks. Short-term adverse events of statin therapy were not common in Korean patients with a low discontinuation rate.

De-escalation of dual-antiplatelet therapy through dose reduction of prasugrel improved net adverse clinical events (NACEs) after acute coronary syndrome (ACS), mainly through the reduction of bleeding without an increase in ischemic outcomes. Whether the benefits of de-escalation are sustained in highly thrombotic conditions such as ST-elevation myocardial infarction (STEMI) is unknown. We aimed to assess the efficacy and safety of de-escalation therapy in patients with STEMI or non-ST-segment elevation ACS (NSTE-ACS).This is a pre-specified subgroup analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomized to prasugrel de-escalation (5 mg daily) or conventional dose (10 mg daily) at 1-month post-percutaneous coronary intervention. The primary endpoint was a NACE, defined as a composite of all-cause death, non-fatal myocardial infarction, stent thrombosis, clinically driven revascularization, stroke, and bleeding events of grade ≥2 Bleeding Academic Research Consortium (BARC) criteria at 1 year.Among 2,338 patients included in the randomization, 326 patients were diagnosed with STEMI. In patients with NSTE-ACS, the risk of the primary endpoint was significantly reduced with de-escalation (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.48-0.89; p=0.006 for de-escalation vs. conventional), mainly driven by a reduced bleeding. However, in those with STEMI, there was no difference in the occurrence of the primary outcome (HR, 1.04; 95% CI, 0.48-2.26; p=0.915; p for interaction=0.271).Prasugrel dose de-escalation reduced the rate of NACE and bleeding, without increasing the rate of ischemic events in NSTE-ACS patients but not in STEMI patients.

Background There are limited data on the long-term outcome of platinum chromium-based everolimus-eluting stents (PtCr-EES) vs. cobalt chromium-based zotarolimus-eluting stents (CoCr-ZES).Methods and Results:A total of 3,755 patients undergoing percutaneous coronary intervention (PCI) were randomized 2:1 to PtCr-EES or CoCr-ZES, and 96.0% of patients completed the 3-year clinical follow-up. The primary outcome was target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR). At 3 years, TLF occurred in 5.3% and in 5.4% of the PtCr-EES and CoCr-ZES groups, respectively (hazard ratio 0.978; 95% confidence interval 0.730-1.310, P=0.919). There were no significant differences in the individual components of TLF. Routine angiographic follow-up was performed in 38.9% of the total patients. In a landmark analysis of the subgroup that had follow-up angiography, the clinically-driven TLR rate of CoCr-ZES was significantly higher than PtCr-EES group during the angiography follow-up period (P=0.009). Overall definite and probable stent thrombosis rates were very low in both groups (0.5% vs. 0.6%, P=0.677). Conclusions PtCr-EES and CoCr-ZES had similar and excellent long-term outcomes in both efficacy and safety after PCI in an all-comer population.

Background This study sought to investigate the safety of 3‐month dual antiplatelet therapy (DAPT) in patients receiving ultrathin sirolimus‐eluting stents with biodegradable polymer (Orsiro). Methods and Results The SMART‐CHOICE (Smart Angioplasty Research Team: Comparison Between P2Y12 Antagonist Monotherapy vs Dual Anti‐ platelet Therapy in Patients Undergoing Implantation of Coronary Drug‐Eluting Stents) randomized trial compared 3‐month DAPT followed by P2Y12 inhibitor monotherapy with 12‐month DAPT in 2993 patients undergoing percutaneous coronary intervention. The present analysis was a prespecified subgroup analysis for patients receiving Orsiro stents. As a post hoc analysis, comparisons between Orsiro and everolimus‐eluting stents were also done among patients receiving 3‐month DAPT. Of 972 patients receiving Orsiro stents, 481 patients were randomly assigned to 3‐month DAPT and 491 to 12‐month DAPT. At 12 months, the target vessel failure, defined as a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization, occurred in 8 patients (1.7%) in the 3‐month DAPT group and in 14 patients (2.9%) in the 12‐month DAPT group (hazard ratio [HR], 0.58; 95% CI, 0.24–1.39; P =0.22). In whole population who were randomly assigned to receive 3‐month DAPT (n=1495), there was no significant difference in the target vessel failure between the Orsiro group and the everolimus‐eluting stent group (n=1014) (1.7% versus 1.8%; HR, 0.96; 95% CI, 0.41–2.22; P =0.92). Conclusions In patients receiving Orsiro stents, clinical outcomes at 1 year were similar between the 3‐month DAPT followed by P2Y12 inhibitor monotherapy and 12‐month DAPT strategies. With 3‐month DAPT, there was no significant difference in target vessel failure between Orsiro and everolimus‐eluting stents. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02079194.

This study aimed to compare the mean pulse rate (PR) and mean blood pressure (BP) between patients with obstructive sleep apnea (OSA) and those with simple snoring (SS) during a 24-hour period, and to investigate the correlation between apnea-hypopnea index (AHI), PR, and BP in sleep-related breathing disorder (SRBD) patients with and without hypertension, diabetes mellitus (DM), and cardiovascular diseases (CVDs).Ninety SRBD patients underwent full-night polysomnography, and ambulatory BP and PR were monitored for 24 hours. Participants were classified into OSA (AHI ≥ 5) and control (SS) (AHI5) groups, and BP and PR were compared. Participants were also divided into groups with and without hypertension, CVDs, or DM to analyze the correlation between AHI, BP, and PR in each group.Mean PRs during the daytime period and during the whole 24-hour period in the OSA group were significantly higher than those in the SS group after controlling for potential confounders. No significant difference was observed in mean BP between the groups. Partial correlation analysis after controlling for confounders showed significant correlation between AHI and PR during daytime and the 24-hour period in participants without hypertension, DM, or CVDs, but not in participants with these conditions.The significant differences and correlations only in PR (not in BP) found in this study suggest that PR could be an early marker for SRBD in individuals without comorbidities, and that an increased sympathetic tone could be responsible for future occurrence of CVD.

The aim of this study was to evaluate the efficacy and tolerability of rosuvastatin/ezetimibe combination therapy in Korean patients with high cardiovascular risk.This was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 337 patients were screened. After a 4-week run-in period, 245 of these patients with high or moderately high risk as defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines were randomly assigned. Patients received 1 of 6 regimens for 8 weeks as follows: (1) rosuvastatin 5 mg, (2) rosuvastatin 5 mg/ezetimibe 10 mg, (3) rosuvastatin 10 mg, (4) rosuvastatin 10 mg/ezetimibe 10 mg, (5) rosuvastatin 20 mg, or (6) rosuvastatin 20 mg/ezetimibe 10 mg. The primary outcome variable was percentage change in the level of LDL-C at week 8 of drug treatment. Secondary outcome variables included percentage changes of other lipid variables and achievement rates of LDL-C targets. Tolerability analyses were also performed.The percentage change of LDL-C ranged from -45% to -56% (mean, -51%) in the monotherapy groups and from -58% to -63% (mean, -60%) in the combination therapy groups. The percentage change was greater in the pooled combination therapy group than in the counterpart (P0.001 for the pooled groups); this difference was more obvious for regimens with a lower statin dose. The percentage reductions of total cholesterol and triglycerides were greater in the combination groups than in the monotherapy groups. The LDL-C target achievement rates were 64% to 87% (mean, 73%) in the monotherapy groups and 87% to 95% (mean, 91%) in the combination groups (P = 0.01 for the pooled groups). The rates were significantly greater in patients receiving the combination therapy than in the monotherapy at lower doses of rosuvastatin. The proportions of patients with various adverse events were not significantly different between the groups.Rosuvastatin/ezetimibe combination therapy has better efficacy and target achievement rates than rosuvastatin monotherapy in patients with high cardiovascular risk.

Background and objectives Diffuse long coronary artery disease (DLCAD) still has unfavorable clinical outcomes after successful percutaneous coronary intervention (PCI). Therefore, we aimed to evaluate the effectiveness and safety of Resolute™ zotarolimus-eluting stent (R-ZES; Resolute™ Integrity) for patients with DLCAD. Methods From December 2011 to December 2014, 1,011 patients who underwent PCI using R-ZES for CAD with longer than 25 mm lesion were prospectively enrolled from 21 hospitals in Korea. We assessed the clinical outcome of major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically-driven target vessel revascularization at 12 months. Results Mean age was 63.8±10.8 years, 701 (69.3%) patients were male, 572 (87.0%) patients had hypertension, 339 (33.8%) patients had diabetes, 549 (54.3%) patients diagnosed with acute MI and 545 (53.9%) patients had multi-vessel disease (MVD). A total of 1,697 stents were implanted into a total of 1,472 lesions. The mean diameter was 3.07±0.38 mm and the length was 28.27±6.97 mm. Multiple overlapping stents were performed in 205 (13.8%) lesions. A 12-month clinical follow-up was available in 1,004 patients (99.3%). The incidences of MACE and definite stent thrombosis at 12-month were 3.0% and 0.3% respectively. On multivariate Cox-regression analysis, multiple overlapping stents implantation, previous congestive heart failure, MVD, and age ≥75 years were independent predictors of one-year MACE. Conclusions Our study shows that R-ZES has an excellent 1-year clinical outcome in Korean patients with DLCAD.

The POST (the effects of postconditioning on myocardial reperfusion in patients with ST-Segment elevation myocardial infarction) study showed that ischemic postconditioning did not improve myocardial reperfusion in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). However, it has not been determined whether postconditioning is effective in women. This study sought to evaluate the impact of sex differences on ischemic postconditioning during the primary PCI. We analyzed clinical outcomes at 1 year in the 537 men and 163 women with STEMI, who were randomized to the postconditioning or to the conventional PCI group. Women were older, had higher rates of hypertension, were less likely to be current smokers, and had longer symptom-to-reperfusion time. The rate of major adverse cardiac events (MACE: a composite of death, myocardial infarction, severe heart failure, stent thrombosis, or target vessel revascularization) at 1 year was higher in women compared to men (9.8% vs. 5.4%, p = 0.044). MACE was significantly higher in women compared to men in the postconditioning group (12.2% vs. 5.4%, p = 0.042), but not in the conventional PCI group (7.9% vs. 5.4%, p = 0.391). However, women was not an independent predictor after adjusting baseline risk factors, angiographic and procedural parameters (HR 2.67, 95% CI 0.68–10.5, p = 0.158). Despite women having more adverse clinical characteristics, their prognosis was similar to men in the conventional group. Although women showed a higher rate of the MACE compared to men, women were not an independent predictor in the postconditioning group.

The aim of this study was to evaluate the blood pressure-lowering and cholesterol-lowering effects of a fixed-dose combination therapy using candesartan (CND)/rosuvastatin (RSV) compared with CND or RSV monotherapy in patients with hypertension and hypercholesterolemia.This study was a 12-week, randomized, double-blind, placebo-controlled, multicenter study. A total of 394 patients were screened. After a 4-week run-in period, 219 of these patients with hypertension and primary hypercholesterolemia were randomized. Patients received 1 of 3 regimens for 8 weeks: (1) CND 32 mg/RSV 20 mg, (2) RSV 20 mg, or (3) CND 32 mg. The primary outcome variables were changes in the systolic blood pressure (SBP) and diastolic blood pressure (DBP) and the percentage changes in LDL-C from baseline to the drug treatment at 8 weeks. The secondary outcome variables were percentage changes of total cholesterol, triglycerides, HDL-C, non-HDL-C, apolipoprotein B, apolipoprotein A-I, high-sensitivity C-reactive protein, and glucose metabolic indices, including percentage changes of the homeostasis model assessment of insulin resistance (HOMA-IR), adiponectin, and hemoglobin AThe percentage changes of LDL-C were -48.6% (from 157.2 to 80.1 mg/dL) in the RSV group and -49.8% (from 160.2 to 78.9 mg/dL) in the CND/RSV group from baseline to the end of 8 weeks of treatment. Mean SBP and DBP were significantly decreased in the CND/RSV and CND groups after 8 weeks (P 0.001 for all); however, no significant differences were found between the 2 groups. Total cholesterol levels, triglycerides, non-HDL-C, and apolipoprotein B were significantly reduced in the CND/RSV and RSV groups, with no significant differences between the groups compared with the CND group (P 0.001 for all). The percentage changes of HOMA-IR, adiponectin, and hemoglobin AOnce-daily fixed-dose combination therapy with CND/RSV is an effective, tolerable, convenient treatment option for patients with essential hypertension and hypercholesteremia. ClinicalTrials.gov identifier: NCT02770261.

The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension.Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ≥ 90 mm Hg in part 1 were enrolled to the up-titration extension study with lercanidipine 20 mg/valsartan 160 mg (L20/V160) (part 2).Of 772 patients screened, 497 were randomized to 3 groups (166 in the L10 group, 168 in the L10/V80 group, and 163 in the L10/V160 group). Mean (SD) age was 55 (9.9) years, and male patients comprised 69%. The mean (SD) baseline systolic blood pressure (SBP)/DBP were 148.4 (15.1)/94.3 (9.5) mm Hg. No significant differences were found between groups in baseline characteristics except the percentages of previous history of antihypertensive medication. The primary end points, the changes of mean (SD) DBP at week 8 from the baseline were -2.0 (8.8) mm Hg in the L10 group, -6.7 (8.5) mm Hg in L10/V80 group, and -8.1 (8.4) mm Hg in L10/V160 group. The adjusted mean difference between the combination groups and the L10 monotherapy group was -4.6 mm Hg (95% CI, -6.5 to -2.6; P0.001) in the L10/V80 group and -5.9 mm Hg (95% CI, -7.9 to -4.0, P0.001) in the L10/V160 group, which had significantly greater efficacy in BP lowering. A total of 74 patients were enrolled in the part 2 extension study. Changes of mean (SD) DBP and SBP from week 8 to week 12 and week 16 were -5.6 (7.9)/-8.0 (12.0) mm Hg and -5.5 (7.0)/-8.5 (11.3) mm Hg, respectively. For evaluation of the safety profile, the frequencies of adverse events between groups were also not significantly different. The most frequently reported adverse events were headache (6 cases, 20.7%) in the L10 group, dizziness (8 cases, 16.3%) in L10/V80 group, and nasopharyngitis (3 cases, 9.4%) in L10/V160 group, and the incidences of adverse events were not different between groups.Treatment of L10/V80 or L10/V160 combination therapy resulted in significantly greater BP lowering compared with L10 monotherapy. Moreover, the L20/V160 high dose combination had additional BP lowering effect compared with nonresponders with the L10/V160 combination. ClinicalTrials.gov: NCT01928628.

List of Institutional Review Boards. (DOCX 18 kb)

Background Hypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events. The objective of this study was to evaluate the efficacy and safety of the co-administration of fimasartan and rosuvastatin in patients with hypertension and hypercholesterolemia. Methods We conducted a randomized double-blind and parallel-group trial. Patients who met eligible criteria after 4 weeks of therapeutic life change were randomly assigned to the following groups. 1) co-administration of fimasartan 120 mg/rosuvastatin 20 mg (FMS/RSV), 2) fimasartan 120 mg (FMS) alone 3) rosuvastatin 20 mg (RSV) alone. Drugs were administered once daily for 8 weeks. Results Of 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8 weeks of treatment, the FMS/RSV treatment group showed greater reductions in sitting systolic (siSBP) and diastolic (siDBP) blood pressures than those in the group receiving RSV alone (both p

Rectus sheath hematoma, caused by rupture of epigastric vessel or muscle tear, is most frequently encountered in association with anticoagulation therapy, trauma, operation, and hematologic disorder. It rarely occurs spontaneously. Rectus sheath hematoma related to subcutaneous injection of insulin is very rare. We report a case of percutaneous catheterbased coil embolization for treatment of rectus sheath hematoma caused by subcutaneous injection of insulin on abdomen during anticoagulation and antiplatelet therapy in an 83-year-old thin woman with diabetes.

Objectives This study sought to test whether the newly developed platinum chromium (PtCr)-based everolimus-eluting stent (EES) is noninferior to the cobalt chromium (CoCr)-based zotarolimus-eluting stent (ZES) in all-comers receiving percutaneous coronary intervention (PCI). Background PtCr provides improved radial strength, conformability, and visibility compared with the CoCr alloy, but PtCr-based stents have not been tested in a wide range of patients receiving PCI. Also, recent case series have raised the issue of longitudinal stent deformation (LSD) with newer drug-eluting stents. Methods We randomly assigned 3,755 all-comers receiving PCI to PtCr-EES or CoCr-ZES. The primary outcome was target lesion failure (TLF) at 1-year post-PCI, defined as the composite of cardiac death, nonfatal target vessel–related myocardial infarction, and ischemia-driven target lesion revascularization. Post-hoc angiographic analysis was performed to qualitatively and quantitatively analyze LSD. Results At 1 year, TLF occurred in 2.9% and 2.9% of the population in the PtCr-EES and CoCr-ZES groups, respectively (superiority p = 0.98, noninferiority p = 0.0247). There were no significant differences in the individual components of TLF as well as the patient-oriented clinical outcome. Of 5,010 stents analyzed, LSD occurred in 0.2% and 0% in the PtCr-EES and CoCr-ZES groups, respectively (p = 0.104). There was no significant difference in post-deployment stent length ratio between the 2 stents (p = 0.352). Conclusions At 1 year, PtCr-EES was noninferior to CoCr-ZES in all-comers receiving PCI. Although LSD was observed only in PtCr-EES, both the stent length ratio and the frequency of LSD were not significantly different between the 2 stent types, and PtCr-EES was not associated with adverse clinical outcomes. (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis–SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen [HOST–ASSURE]; NCT01267734 )

Background— Ischemic postconditioning has been reported to reduce infarct size in patients with ST-segment–elevation myocardial infarction. However, cardioprotective effects of postconditioning have not been demonstrated in a large-scale trial. Methods and Results— We performed a multicenter, prospective, randomized, open-label, blinded end-point trial. A total of 700 patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment–elevation myocardial infarction within 12 hours after symptom onset were randomly assigned to the postconditioning group or to the conventional primary PCI group in a 1:1 ratio. Postconditioning was performed immediately after restoration of coronary flow as follows: The angioplasty balloon was positioned at the culprit lesion and inflated 4 times for 1 minute with low-pressure (70%) measured at 30 minutes after PCI. Complete ST-segment resolution occurred in 40.5% of patients in the postconditioning group and 41.5% of patients in the conventional PCI group (absolute difference, −1.0%; 95% confidence interval, −8.4 to 6.4; P =0.79). The rate of myocardial blush grade of 0 or 1 and the rate of major adverse cardiac events (a composite of death, myocardial infarction, severe heart failure, or stent thrombosis) at 30 days did not differ significantly between the postconditioning group and the conventional PCI group (17.2% versus 22.4% [ P =0.20] and 4.3% versus 3.7% [ P =0.70], respectively). Conclusion— Ischemic postconditioning did not improve myocardial reperfusion in patients with ST-segment–elevation myocardial infarction undergoing primary PCI with current standard practice. Clinical Trial Registration— URL: http://clinicaltrials.gov . Unique identifier: NCT00942500.

The aim of the study was to assess the accuracy of the three-dimensional (3D) quantitative coronary analysis (QCA) system by comparing with that of intravascular ultrasound (IVUS) QCA and two-dimensional (2D) QCA. 3D QCA, 2D QCA and IVUS QCA were performed in 45 vessel segments. The obtained values for the branch to branch segment vessel length and the proximal part of the segment vessel’s lumen diameter were measured. Inter-technique agreement was analyzed using paired sample t-test and Bland–Altman analysis. No differences were found in vessel lengths taken by 3D QCA and IVUS QCA (mean difference: 0.29 ± 1.06 mm, P = 0.07). When compared with IVUS QCA, 2D QCA underestimated vessel length (mean difference: −1.78 ± 2.55, P

Background and Objectives The plasma concentration of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) is a st-rong prognostic indicator for patients with heart failure (HF) across all stages of the condition. Several clinical trials have de-monstrated convincingly that neurohormonal modulation on the renin angiotensin system (RAS) decreases plasma NT-pro-BNP level and results in favorable outcomes. But there are still limited comparative data on the neuro-hormonal modulatory effects of two RAS inhibitors: angiotensin converting enzyme inhibitor and angiotensin receptor blocker. Subjects and Methods This study was a prospective, multi-center, randomized, open-label, controlled, and non-inferiority study involving 445 patients with left ventricular ejection fraction (LVEF) less than 45%. Patients were assigned to receive either valsartan (target dose of 160 mg bid) or enalapril (target dose of 10 mg bid) for 12 months. We compared plasma NT-pro-BNP, high sensitive C-reactive protein (hs-CRP) level and echocardiographic parameters before and after treatment with valsartan or enalapril. Results: The NT-pro-BNP and hs-CRP levels were significantly decreased after 12 months of treatment with valsartan and enalapril. The percentage change was similar between both groups. LVEF improved and left ventricular internal dimensions were decreased in both groups, and there were no significant differences between two groups. Conclusion Valsartan is as effective on improving plasma NT-pro-BNP level as enalapril in patients with stable chronic HF.

Right sided aortic arch is an uncommon congenital anomaly. It can be classified into three types, depending on the left aortic arch's degenerating pattern and the branching pattern of the great vessels. It can be associated with major congenital heart disease, depending on the type of right sided aortic arch. We report a case of an 18-years-old female who has right sided aortic arch with atrial septal defect (ASD). In our case, the patient had a right sided aortic arch and aberrant left subclavian artery, also she had ASD (ostium secundum) and moderate tricuspid regurgitation with pulmonary hypertension. The patient was successfully performed patch closure of ASD and tricuspid valve annuloplasty via midline sternotomy. The patient had uneventful postoperative course.

Background In the Effects of Postconditioning on Myocardial Reperfusion in Patients with ST-segment Elevation Myocardial Infarction (POST) trial, ischemic postconditioning failed to improve myocardial reperfusion. However, long-term effects of ischemic postconditioning on clinical outcomes are not known in patients with ST-segment elevation myocardial infarction. Methods A total of 700 patients undergoing primary percutaneous coronary intervention (PCI) were randomly assigned to the postconditioning group or the conventional primary PCI group in a 1:1 ratio. Postconditioning was performed immediately after restoration of coronary flow by balloon occlusion 4 times for 1 minute. Complete follow-up data for major clinical events at 1 year were available in 695 patients (99.3%), and analyses were done by the intention to treat principle. The primary outcome was a composite of death, myocardial infarction, severe heart failure, or stent thrombosis at 1 year. Results At 1 year, a composite of death, myocardial infarction, severe heart failure, or stent thrombosis occurred in 21 patients (6.1%) in the postconditioning group and 16 patients (4.6%) in the conventional PCI group (hazard ratio [HR] 1.32, 95% CI 0.69-2.53, P = .40). The risk of death (4.9% vs 3.7%, HR 1.32, 95% CI 0.64-2.71, P = .46), heart failure (2.6% vs 2.3%, HR 1.13, 95% CI 0.44-2.94, P = .80), and stent thrombosis (2.3% vs 1.7%, HR 1.34, 95% CI 0.46-3.85, P = .59) did not differ significantly between the 2 groups. Conclusions Ischemic postconditioning does not seem to improve the 1-year clinical outcomes in patients with ST-segment elevation myocardial infarction undergoing primary PCI.

We thank Dr Kong and Dr Morel for their comments on our study.1 However, although the negative findings of the Effects of Postconditioning on Myocardial Reperfusion in Patients With ST-Segment Elevation Myocardial Infarction (POST) trial may result from study design, we do not fully agree with their opinions. First, Dr Kong and Dr Morel claimed that ballooning for ischemic postconditioning should be performed proximal to the culprit lesion rather than within the stent to reduce microembolism. However, there is no direct evidence on association between the location of ballooning for ischemic postconditioning and microembolism or infarct size during primary percutaneous coronary intervention (PCI). Moreover, as we described, the balloon was inflated with low-pressure (

Objective: The aim of this study was to assess heart rate (HR) responses to exercise in the prediction of the major adverse cardiovascular events (MACE) in patients with revascularization. Methods: We retrospectively analyzed 253 patients with successful revascularization and exercise treadmill test (ETT) 4 months later in asymptomatic status. MACE was defined as cardiac death, nonfatal myocardial infarction and revascularization. HR reserve as index of chronotropic response was calculated as (peak HR-baseline HR) ×100/(220-age-baseline HR). Impaired HR reserve was defined as achievement of

BACKGROUND AND OBJECTIVES There is little information about the relationship between the Doppler flow of the ophthalmic artery (OA) and carotid and coronary atherosclerosis. The aim of the investigation was to assess the clinical usefulness of the Doppler flow of the OA to estimate the severity of carotid and coronary atherosclerosis. SUBJECTS AND METHODS The study was a retrospective analysis of the findings in 140 patients (mean age: 60 years, male: 64%) who underwent coronary angiography (CA) for the evaluation of typical angina between July 2010 and October 2011 in our single center. The severity of coronary artery stenosis was based on the Gensini score (GS). Significant coronary artery disease (CAD) was defined as the obstruction of over 75% of the major coronary arteries confirmed with CA. The pulsed Doppler flow of the OA and carotid ultrasound were performed before CA. RESULTS The mean systolic velocity/mean diastolic velocity (MSV/MDV), pulsatile index and resistance index in the Doppler flow of the OA were identified as significant and independent correlations with carotid intima-media thickness, and MSV/MDV was identified to have a significant and independent correlation with the GS. MSV/MDV >2.1 was the independent predictor for significant CAD {odds ratio (OR) 3.8, 95% confidence interval (CI) 1.5-9.7, p=0.005} and carotid plaque (OR 2.8, 95% CI 1.1-7.0, p=0.028), after adjustment for CAD-associated factors. CONCLUSION The Doppler flow of the OA might be a useful predictor of the severity of carotid and coronary atherosclerosis.

The objective of the present study was to assess global and regional left ventricular diastolic function in SLE patients when compared to healthy individuals using echocardiography. A total of 104 SLE patients (mean age: 43.7 years, female: 96) were enrolled and matched to 104 control subjects on

Vulnerable plaques are characterized by large lipid cores, positive remodeling and small coronary calcium deposits. Multi-detector computed tomography (MDCT) has recently been shown to be able to characterize coronary artery plaques. The aim of this study was to evaluate culprit coronary lesions for differentiating acute coronary syndrome (ACS) from stable angina pectoris (SAP) using MDCT. 64-slice MDCT was conducted on 71 patients (ACS: 35, SAP: 36). The culprit coronary lesions were assessed according to the type and plaque attenuation (PA) of the plaque and the remodeling index (RI) as the ratio of the lesion and the reference area. The culprit lesion score (CLS) was defined as the sum of every score as 1.2 for a PA ≤ 60 Hounsfield units (HU), 1.1 for a RI ≥ 1.05 and 1.2 for a non-calcified or spotty calcification. More spotty calcification (95.0% vs. 23.1%, P < 0.001), a lower PA (40.17 ± 20.08 HU vs. 96.96 ± 58.19 HU, respectively, P < 0.001) and a higher RI (1.44 ± 0.43 vs. 0.90 ± 0.44, respectively, P < 0.001) were observed in the ACS patients. Also, the CLS of the ACS patients was significantly higher than that of the SAP patients (3.07 ± 0.63 vs. 1.18 ± 1.12, respectively, P < 0.001). A CLS more than 2.0 helped us to differentiate ACS from SAP with a sensitivity of 97.1% and a specificity of 67.6%. The CLS might be a useful tool for differentiating ACS from SAP.

The American Heart Association estimates that one in five deaths from cardiovascular disease are directly linked to cigarette smoking. Individuals who smoke are two to six times more likely to develop coronary artery disease than nonsmokers. However, individuals who quit smoking will reduce their risk to levels equivalent to those of a nonsmoker within three years. Refer to the page 119-124 Exposure to cigarette smoke is an established risk factor for coronary heart disease in both Western and Asian countries. The multivariate relative risk of coronary heart disease mortality for current smokers was 1.8-3.7 compared to nonsmokers.1) Poor prognosis in smokers results from: 1) induction of hypercoagulability due to increased platelet activation, dyslipidemia, and endothelial dysfunction; 2) increased catecholamine release leading to increased heart rate, blood pressure, coronary vasoconstriction, and even arrhythmogenic effect; and 3) reduction in oxygen delivery due to increased carbon monoxide levels.2) The term of "smoker's paradox" has been coined by Barbash et al.3) who reported better outcomes among the smokers receiving thrombolytic therapy for acute myocardial infarction. Similarly, Cohen et al.4) reported that cigarette smoking was associated with a lower rate of subsequent target lesion revascularization in patients undergoing percutaneous coronary intervention (PCI). Hasdai et al.5) reported that current smokers during an index percutaneous intervention had fewer adverse events in the univariable analysis than the nonsmokers and former smokers. This improved can be explained in part by better covariables such as younger age or a more favorable clinical and angiographic profile. Therefore, this term may be misleading.6) Clopidogrel, an inhibitor of the platelet P2Y12 adenosine diphosphate receptor, improves prognosis in patients with acute coronary syndrome (ACS). However, there is significant response variability and a diminished clopidogrel response is associated with an increased risk of ischemic events.7) Smoking induces cytochrome P450 1A2 (CYP1A2), a hepatic enzyme involved in the metabolism of clopidogrel. Clopidogrel shows better inhibition of platelet aggregation in smokers than nonsmokers,8) and smokers are less likely to be hyporesponders than nonsmokers.9) In this issue of the Journal, Cho et al.10) investigated the association between smoking status and post-clopidogrel platelet reactivity in patients with acute myocardial infarction. Differences in the clinical situation and timing of the platelet test could explain the differences with the Bliden study.8) The decreases in CYP1A2 activity induced by smoking may also disappear after three days. The CHARISMA (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance) trial compared long-term clopidogrel 75 mg/day vs. placebo in patients at high risk for cardiovascular events, and clopidogrel significantly reduced mortality in smokers but not in former or never-smokers.11) In addition to CYP1A2 activation by smoking, smokers may simply be a higher-risk group because of enhanced platelet activity and therefore benefit more from antithrombotic intervention. The Clopidogrel as Adjunctive Reperfusion Therapy-Thrombolysis In Myocardial Infarction 28 (CLARITY-TIMI 28) trial compared the effect of clopidogrel on angiographic and clinical outcomes in 3,429 ST elevation myocardial infarction patients by smoking intensity: not current smokers (n=1,732), and smokers of 1 to 9 (n=206), 10 to 19 (n=354), 20 to 29 (n=715), and ≥30 cigarettes/day (n=422). Clopidogrel reduced the primary end point of a closed infarct-related artery or death/myocardial infarction, particularly among those who smoked ≥10 cigarettes/day.12) The CURRENT-OASIS 7 (Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent Events/Optimal Antiplatelet Strategy for Interventions) trial, which tested high-dose vs. usual-dose clopidogrel in ACS patients undergoing PCI, showed that smokers (vs. nonsmokers) had significant benefit with the higher clopidogrel dose. Smoking increases the risk for cardiovascular events and mortality in patients with established cardiovascular disease, but clopidogrel treatment may be more effective in smokers. Therefore, the interaction of smoking with acute myocardial infarction deserves further study in more patients using designs that show fewer time limitations.

Background: The myocardial bridge (MB) is an intramural segment of coronary artery that is covered with myocardial tissue. The current diagnostic methods are coronary angiography, intravascular ultrasound and intracoronary Doppler, which are all invasive modalities. In this study, multidetector computed tomography (MDCT) was used to detect and evaluate the anatomical properties of the MB. Methods and Results: The 607 patients with suspected or known coronary artery disease underwent 64-slice MDCT. MB was diagnosed when an intramural segment of coronary artery was visualized on axial and multiplanar reconstruction images. The prevalence, length, myocardial thickness, and location were evaluated. Of the 607 patients, 39 (6.42%) had a MB. In 20 patients (52.6%), the MB was located in the mid left anterior descending artery. The length of tunneled artery was a mean 16.3 mm, from 6.9 mm to 30 mm, and the maximum thickness of the myocardial tissue was between 0.5 mm and 3.9 mm, with a mean of 1.8 mm. The length of the MB correlated significantly with thickness (P=0.049). Conclusions: The incidence of MB and its anatomical properties can be evaluated with MDCT, which might be a useful and noninvasive method of detecting this variant. (Circ J 2010; 74: 137 - 141)

Background: Masked hypertension (MH) has been drawing attention recently because this condition is often seen in untreated and treated individuals and is associated with target organ damage and a poor cardiovascular prognosis. Arterial stiffness is associated with organ damage in patients with primary hypertension. The aim of this study was to evaluate pulse wave velocity (PWV) in MH and true hypertension (TH). Methods: We enrolled 146 patients (mean age 47.9±13.9 yrs, male 78 (53.4 %)), who was recently diagnosed as hypertension. MH was defined as office normotension (systolic blood pressure(SBP)

Cor triatriatum dexter is a rare congenital anomaly caused by persistence of the right valve of the embryonic sinus venosus, and this results in septation of the right atrium. Three-dimensional echocardiography is a novel technique that can be used to identify and characterize this entity. Here, we report two women with cor triatriatum dexter.